I think that some people are not surprised by this article. I am not surprised as I have had a niggling in the back of my mind about this when well established FDA approved drugs end up in trials without FDA making the request. This article in medscape dot com finally puts this out for doctors and research clinicians to see what happens.
This is one time that Parke-Davis, a subsidiary of Pfizer, got exposed for their unethical practices. If it had not been for litigation against Parke-Davis for illegally marketing gabapentin (Neurontin), this may not have seen the light of day.
Joseph S. Ross, MD, MHS, from Yale University School of Medicine, New Haven, Connecticut, and his colleagues were consultants to the plaintiffs and so had access to emails, memos, depositions, and other documents uncovered during the litigation. In studing these materials, they came to the conclusion that the trial was really being used for marketing purposes.
G. Caleb Alexander, MD, from the University of Chicago, Illinois, commented in an accompanying editorial that seeding trials threaten the integrity of phase 4 clinical trials.
Dr Alexander did offer some tips for physicians and patients so that they can avoid becoming participants in “seeding trials”. He said that clinicians should be on the lookout for the following characteristics of the study.
Does the study investigate a compelling scientific question? If no – red flag up.
Is there a large number of investigators with a small number of patients per investigator? If yes – red flag up.
Do the investigators themselves have limited to no clinical trial experience? If yes – red flag up.
If the clinician asks if the marketing division has a role in the conduct of the trial? If yes – large red flag up - waving.
To this Dr. Ross adds, if the company only wants you to enroll 5 to 10 patients – please be wary. They may not be interested in the drug as they may be more interested in you for future sales.
Dr. Ross says that participating in one of these trials is not illegal, but is unethical. It violates a number of ethical norms and clinical trial conduct rules. The patients are exposed to some risk because they are not aware that the trial is a marketing trial.
These types of studies very seldom see print because they involve deception, but this is interesting from what this trial reveals about the the drug companies and the lengths they will go to for sales.
Read part of accompanying editorial here, and the abstract here.
July 9, 2011
July 8, 2011
How Would You React? - P3
(Continued from the last blog - P2) Then a few weeks ago now, they emailed me wanting to know why on a site they had found, the person was so upset about people asking about a number on the meter. It is this blog and I have tried to explain it. I told them that a lot of people don't like to talk about numbers and value their privacy more than talking about numbers, and in this case, it was plainly rude. That while one number does not mean much in and of itself to some people, others rely on this number at the point in time for information in that moment. Others look at the number for the direction their blood glucose may be trending.
While those of us with Type 2 diabetes are looking for trends in our numbers and use them for regulating our food intake, those with Type 1, seem mainly concerned that they have given themselves the correct amount of insulin for the food (carbs) eaten and whether they are going higher, or are on the way to a low. If wearing a continuous glucose monitor, the number is not so much the concern as the direction and speed at which numbers are changing and how much longer the insulin will last. It can be contextual in these circumstances, but for those of us with Type 2, it can indicate trends.
We look at the numbers as indicators of trends that we may need to adjust for in the long-term. This is very true for Type 2's on oral medications and those using exercise and diet to manage diabetes. Those of us Type 2's on insulin do a lot more carb counting and try to cover the carbs to be eaten like the Type 1's, but also are looking for trends and possible insulin resistance.
This of course raised the issue of why the concern. So I took time to explain the diabetes police and some of the other problems that would come her way when school started. I said that if she wanted, she should discuss this with other Type 1's. Fortunately, there were several Type1's available and we had a good meeting the following Saturday, a few laughs, and I think the family came away with a better understanding of the problems of being out in the public or even family gatherings.
The one point everyone raised was to take advantage of the summer and test often as the endo had asked her to do. This would help her confidence and she would recognize the symptoms of heading into a low and know what to do immediately. To watch out if she did not recognize the symptoms and talk to the endo immediately if this happened, to see if a continuous glucose monitor may be necessary. One of the group is that way and showed the family the instrument they were talking about. Then they discussed pumps and among the four there were three different brands.
The biggest thing the group of T1's emphasized was learning how to count carbs and determining the insulin dosage. We discussed many of the sites that would help calculate carbs and other nutrition information. We looked at several of the cookbooks the family had and she had one of the newer versions with the nutrition information with each recipe. The daughter had pulled up several of the sites and bookmarked them as we looked at the cookbooks. I could see the relief on her mother's face.
I know all of the group passed the family phone numbers and said if they had questions to ask. And the last item before we left was to give them advice on meeting with the school nurse and principal before school was to start. The 12-year old really won the hearts of everyone when she thanked each person for their time and input and willingness to be a resource for her to lean on.
As a person with Type 2, I had to admire these people for opening up together and coming to the support of this family. This is so different from what most of my Type 2 friends do. We acknowledge each other, but seldom talk about diabetes individually or when we are together as a group unless it is a support group meeting.
End of this series – there may be more later.
While those of us with Type 2 diabetes are looking for trends in our numbers and use them for regulating our food intake, those with Type 1, seem mainly concerned that they have given themselves the correct amount of insulin for the food (carbs) eaten and whether they are going higher, or are on the way to a low. If wearing a continuous glucose monitor, the number is not so much the concern as the direction and speed at which numbers are changing and how much longer the insulin will last. It can be contextual in these circumstances, but for those of us with Type 2, it can indicate trends.
We look at the numbers as indicators of trends that we may need to adjust for in the long-term. This is very true for Type 2's on oral medications and those using exercise and diet to manage diabetes. Those of us Type 2's on insulin do a lot more carb counting and try to cover the carbs to be eaten like the Type 1's, but also are looking for trends and possible insulin resistance.
This of course raised the issue of why the concern. So I took time to explain the diabetes police and some of the other problems that would come her way when school started. I said that if she wanted, she should discuss this with other Type 1's. Fortunately, there were several Type1's available and we had a good meeting the following Saturday, a few laughs, and I think the family came away with a better understanding of the problems of being out in the public or even family gatherings.
The one point everyone raised was to take advantage of the summer and test often as the endo had asked her to do. This would help her confidence and she would recognize the symptoms of heading into a low and know what to do immediately. To watch out if she did not recognize the symptoms and talk to the endo immediately if this happened, to see if a continuous glucose monitor may be necessary. One of the group is that way and showed the family the instrument they were talking about. Then they discussed pumps and among the four there were three different brands.
The biggest thing the group of T1's emphasized was learning how to count carbs and determining the insulin dosage. We discussed many of the sites that would help calculate carbs and other nutrition information. We looked at several of the cookbooks the family had and she had one of the newer versions with the nutrition information with each recipe. The daughter had pulled up several of the sites and bookmarked them as we looked at the cookbooks. I could see the relief on her mother's face.
I know all of the group passed the family phone numbers and said if they had questions to ask. And the last item before we left was to give them advice on meeting with the school nurse and principal before school was to start. The 12-year old really won the hearts of everyone when she thanked each person for their time and input and willingness to be a resource for her to lean on.
As a person with Type 2, I had to admire these people for opening up together and coming to the support of this family. This is so different from what most of my Type 2 friends do. We acknowledge each other, but seldom talk about diabetes individually or when we are together as a group unless it is a support group meeting.
End of this series – there may be more later.
July 7, 2011
How Would You React? - P2
(Continued from the last blog - P1) We sat down in the Mall and the daughter was full of questions about why the lancet device hurt so much. So it was education time. I asked to see her device and it was the same one that I use. The setting was at one less than the deepest and she had been told to leave it there. I said no, that she could change it to fit her needs and that it was what I had been taught. So we started at the lightest setting and I used mine on my fingers as an example going through several settings. The daughter asked why I did not change lancets each time. I explained that I would have if I was to test on my wife's fingers, but that I did not change until I had too much pain when I used it. I said that she should change when she felt like it or on a certain day each week or month.
Then she ask why I had not used the alcohol pad to sterilize first. I knew then there were problems so I took time to explain that the alcohol pads were only for those times when her finger needed to be sterilized and she could not wash with soap and warm water. I also warned her that if she had been working in the kitchen and handling fruit and some foods, that the alcohol would not remove the sugar and she would get erroneous readings and needed to wash with soap and water to remove the sugar. I also explained that regular use of the alcohol pads would dry out her finger tips and cause cracks in the winter and then testing could be quite painful.
Then she did the lancing and of course flinched. As a result – no blood. I could see that she had been scared on this. So I had her try again with me holding the device so she would not know when it would hit. No flinching and a little blood, but not a sufficient amount for the meter. She said she had no pain, so I set the device to the next level and we repeated. This time there was enough blood for the meter, so she put the test strip where she had been shown and wicked the blood into the test strip. The reading was not great, but for the time of day after a meal, it was acceptable.
We discussed the pressure needed and milking the finger to get sufficient blood. The next one she did on her own and got sufficient blood. She commented that it was a small sting, but not nearly as bad as when she was in the office. We discussed the need for adjusting the device to her own needs and possible differences even on some fingers. The daughter asked if one of the web sites the endo had given them would also cover this. I said it would and from what I remember it is a good site – just not as detailed as it could be.
The daughter said the endo had set up an appointment in two weeks to talk about the pump and some other information. The book they had to order was about pumping and so they would not be ready for the appointment. I knew my neighbor who is a Type 1 had the book and said I would ask him if he would loan it until theirs arrived.
When I returned home, the neighbor said he would loan it, so with my two on counting carbs and his on pumping, I called to say I had them. The husband said he would be by to get them shortly.
When he arrived, we talked further and he thanked me for the two sites I had given them as they were very helpful and he wanted my email and telephone so they could ask questions as they had them. I gave him the information and two other sites for the family to explore. After I sent an email to the endo, I know she sent several more sites including two that I had given.
Continued on the next blog - P3
Then she ask why I had not used the alcohol pad to sterilize first. I knew then there were problems so I took time to explain that the alcohol pads were only for those times when her finger needed to be sterilized and she could not wash with soap and warm water. I also warned her that if she had been working in the kitchen and handling fruit and some foods, that the alcohol would not remove the sugar and she would get erroneous readings and needed to wash with soap and water to remove the sugar. I also explained that regular use of the alcohol pads would dry out her finger tips and cause cracks in the winter and then testing could be quite painful.
Then she did the lancing and of course flinched. As a result – no blood. I could see that she had been scared on this. So I had her try again with me holding the device so she would not know when it would hit. No flinching and a little blood, but not a sufficient amount for the meter. She said she had no pain, so I set the device to the next level and we repeated. This time there was enough blood for the meter, so she put the test strip where she had been shown and wicked the blood into the test strip. The reading was not great, but for the time of day after a meal, it was acceptable.
We discussed the pressure needed and milking the finger to get sufficient blood. The next one she did on her own and got sufficient blood. She commented that it was a small sting, but not nearly as bad as when she was in the office. We discussed the need for adjusting the device to her own needs and possible differences even on some fingers. The daughter asked if one of the web sites the endo had given them would also cover this. I said it would and from what I remember it is a good site – just not as detailed as it could be.
The daughter said the endo had set up an appointment in two weeks to talk about the pump and some other information. The book they had to order was about pumping and so they would not be ready for the appointment. I knew my neighbor who is a Type 1 had the book and said I would ask him if he would loan it until theirs arrived.
When I returned home, the neighbor said he would loan it, so with my two on counting carbs and his on pumping, I called to say I had them. The husband said he would be by to get them shortly.
When he arrived, we talked further and he thanked me for the two sites I had given them as they were very helpful and he wanted my email and telephone so they could ask questions as they had them. I gave him the information and two other sites for the family to explore. After I sent an email to the endo, I know she sent several more sites including two that I had given.
Continued on the next blog - P3
July 6, 2011
How Would You React - P1
NOTE: At request of the parents, no names are being used.
Why all the excitement about a blood glucose meter reading? Oh yes, it is just a number, but those of us with diabetes just happen to live with numbers and by the numbers it does mean something. Should we be upset when someone asks about a number when they see us testing? Many seem to get hyper about it. Yes, many get tired of the diabetes police and related reactions for good reason. Some people are just too nosy for our liking, but what the hey – we have to live too.
Granted, I will probably never be in a similar situation, but over a month ago now, I was at a local restaurant with a fellow type 2, and I had a person at another table asked me what my number happened to be. I had not even noticed them watching me. Since I am not bashful, I said what it was. Turns out that the mother was using this as a teaching moment for her daughter. She apologized for asking, but explained that her daughter of 12 had just been diagnosed that morning.
So for about the next hour, we talked about diabetes and what the meter meant to us. The daughter had been diagnosed as a Type 1, so they were thinking I had to be a Type 1 since I used insulin. After a little explanation, they were full of questions about the differences and why some people seemed so secretive and others like myself just did what I needed to do and went on living.
Granted most of the questions were about Type 1 and if there were similarities between the two types. I found out that they had just been to the endocrinologist. I asked when their next appointment was and was told they would be seeing the CDE and nutritionist the following day. So I answered the questions I could to the best of my ability and said that they should write them down so they could ask them again for the right answer just in case. The daughter reached into her school bag and got a pad and pen and started writing and I think this is key – without being asked.
It was most unfortunate or fortunate depending on how you view it that the next day we both came into the hall outside of adjacent offices at the same time. The mother said hello and the endo asked all of us to step into the room and asked what had happened. The daughter said that she had been told by the CDE to limit her sports participation and not to be talking to people with Type 2 diabetes. The endo asked what sports she was involved in. The answer was basketball, softball and soccer and she was hoping to become involved in track – cross country running.
The endo said she would like to see her after she was completed with the dietitian as she wanted to discuss the pump in light of this and she might delay putting her on the pump (and she has delayed it now). Then she asked the mother what books she was planning to purchase at the bookstore. She mentioned a couple of the books my friend and I had suggested and the endo said good, looked at me and said she was going to give her a couple of others to add to this and we left that meeting so the dietitian could start.
On the way out to get me set up for my next appointment, she commented that I had suggested the right books and she would recommend at least two more and possibly a third. As she prepared to leave, she said it sounds like you have a good grasp on most of the differences between the types and to keep it up. Well, I have a lot to learn yet, but at least I have not steered the mother and daughter wrong.
Since I thought that the mother and daughter would be delayed for at least an hour, I took time to do some shopping and then headed for the bookstore. They had finished early, and were there and had most of the books collected, but had not located two of them. Generally I don't like to loan from my library, but this time I volunteered telling them that it would help them decide which book would fit their needs on carb counting. They placed an order for the one the store did not have in stock and we left.
More in the next blog P2 of three.
Why all the excitement about a blood glucose meter reading? Oh yes, it is just a number, but those of us with diabetes just happen to live with numbers and by the numbers it does mean something. Should we be upset when someone asks about a number when they see us testing? Many seem to get hyper about it. Yes, many get tired of the diabetes police and related reactions for good reason. Some people are just too nosy for our liking, but what the hey – we have to live too.
Granted, I will probably never be in a similar situation, but over a month ago now, I was at a local restaurant with a fellow type 2, and I had a person at another table asked me what my number happened to be. I had not even noticed them watching me. Since I am not bashful, I said what it was. Turns out that the mother was using this as a teaching moment for her daughter. She apologized for asking, but explained that her daughter of 12 had just been diagnosed that morning.
So for about the next hour, we talked about diabetes and what the meter meant to us. The daughter had been diagnosed as a Type 1, so they were thinking I had to be a Type 1 since I used insulin. After a little explanation, they were full of questions about the differences and why some people seemed so secretive and others like myself just did what I needed to do and went on living.
Granted most of the questions were about Type 1 and if there were similarities between the two types. I found out that they had just been to the endocrinologist. I asked when their next appointment was and was told they would be seeing the CDE and nutritionist the following day. So I answered the questions I could to the best of my ability and said that they should write them down so they could ask them again for the right answer just in case. The daughter reached into her school bag and got a pad and pen and started writing and I think this is key – without being asked.
It was most unfortunate or fortunate depending on how you view it that the next day we both came into the hall outside of adjacent offices at the same time. The mother said hello and the endo asked all of us to step into the room and asked what had happened. The daughter said that she had been told by the CDE to limit her sports participation and not to be talking to people with Type 2 diabetes. The endo asked what sports she was involved in. The answer was basketball, softball and soccer and she was hoping to become involved in track – cross country running.
The endo said she would like to see her after she was completed with the dietitian as she wanted to discuss the pump in light of this and she might delay putting her on the pump (and she has delayed it now). Then she asked the mother what books she was planning to purchase at the bookstore. She mentioned a couple of the books my friend and I had suggested and the endo said good, looked at me and said she was going to give her a couple of others to add to this and we left that meeting so the dietitian could start.
On the way out to get me set up for my next appointment, she commented that I had suggested the right books and she would recommend at least two more and possibly a third. As she prepared to leave, she said it sounds like you have a good grasp on most of the differences between the types and to keep it up. Well, I have a lot to learn yet, but at least I have not steered the mother and daughter wrong.
Since I thought that the mother and daughter would be delayed for at least an hour, I took time to do some shopping and then headed for the bookstore. They had finished early, and were there and had most of the books collected, but had not located two of them. Generally I don't like to loan from my library, but this time I volunteered telling them that it would help them decide which book would fit their needs on carb counting. They placed an order for the one the store did not have in stock and we left.
More in the next blog P2 of three.
July 5, 2011
How Doctors Use Fear
I had not intended to do this blog, but one of the diabetes forums had a discussion about doctors and specialists using fear with children. One poster was very angry about the need to change doctors and will not take her child back to see the specialist.
Another poster was in agreement and said that he had taken his son to three different doctors and was still searching for one that would not use fear. He made the statement that - “people...small or adult...respond much better with positive reinforcement.”
It was fairly well established that too many of the specialists used fear to get the patients to follow their orders, but that only caused them to find new doctors or specialists. Most of the responders had gone through three or more doctors and in general were trying to avoid specialists when at all possible.
He also stated “The ego of some specialists is a massive barrier to patient education ... unfortunately I think that the more specialized they are, they can become more narrow in their thinking.” He went on to say “They need to focus FIRST on the child (patient), then the disease.”
I agree very much with the poster's last statement as too many doctors are concerned only with the disease and what they can do to get the patient to follow orders. Little thought is put into any education which could develop positive reinforcement and a patient that wanted to do what was right because it is the best thing to do, both for the patient and the doctor.
How can anyone strive for any goal without hope? Doctors all need some continuing education about giving patients hope and how to use positive reinforcement along with education to help the patient.
While this post is not about insulin per se, it is the fear that doctors try to instill in people that irritates most patients. What those doctors do not realize is that they are losing patients with their attitudes and use of fear. Or they know that they are losing patients and figure that another doctor can put up with them.
The medical profession needs to revise their approach and leave fear out of medicine and replace it with positive approaches and patient education. Will this require more time – yes, but these patients will allow more time for other patients in the future and will be much better patients. Otherwise, in the future, some of these doctors may find themselves without practices.
Another poster was in agreement and said that he had taken his son to three different doctors and was still searching for one that would not use fear. He made the statement that - “people...small or adult...respond much better with positive reinforcement.”
It was fairly well established that too many of the specialists used fear to get the patients to follow their orders, but that only caused them to find new doctors or specialists. Most of the responders had gone through three or more doctors and in general were trying to avoid specialists when at all possible.
He also stated “The ego of some specialists is a massive barrier to patient education ... unfortunately I think that the more specialized they are, they can become more narrow in their thinking.” He went on to say “They need to focus FIRST on the child (patient), then the disease.”
I agree very much with the poster's last statement as too many doctors are concerned only with the disease and what they can do to get the patient to follow orders. Little thought is put into any education which could develop positive reinforcement and a patient that wanted to do what was right because it is the best thing to do, both for the patient and the doctor.
How can anyone strive for any goal without hope? Doctors all need some continuing education about giving patients hope and how to use positive reinforcement along with education to help the patient.
While this post is not about insulin per se, it is the fear that doctors try to instill in people that irritates most patients. What those doctors do not realize is that they are losing patients with their attitudes and use of fear. Or they know that they are losing patients and figure that another doctor can put up with them.
The medical profession needs to revise their approach and leave fear out of medicine and replace it with positive approaches and patient education. Will this require more time – yes, but these patients will allow more time for other patients in the future and will be much better patients. Otherwise, in the future, some of these doctors may find themselves without practices.
July 4, 2011
How Doctors Use The Fear of Insulin
This is one blog that needs to be written, but not for the reasons that many want. This is about the doctors and other healthcare professionals that use insulin as a fear factor and perpetuate the insulin myths.
The insulin myths are just that – a myths. Why is this used by so many doctors? Is it to get compliance with oral medications? - yes. Do the doctors do anything to remove any of the myths and tell the patient that there is nothing to the myths? - seldom. Is it to get patients to make lifestyle changes? - maybe. Is it to get patients to educate themselves? - no.
An editorial (by David Marrero, PhD – Associate Editor) in the July 2010 issue of Diabetes Forecast, that I have a copy of, was written about a year ago and is still relevant today as it was then. The author is a Type 1 and has an excellent understanding of the problems that people with Type 2 diabetes encounter. The last paragraph in the editorial is the best.
Quote – How should you regard insulin if you have type 2 diabetes? Well, of all the treatment options currently available, insulin is the one with which we have the most experience (over 80 years), the least artificial (the human body naturally makes and needs insulin), and often the most potent. It is one of several medications, not a treatment of last resort. If you have type 2, I suggest that you discuss with your doctor whether insulin is a good choice for you now. Don't wait until you have run out of options. Unquote (emphasis is mine).
What is it going to take folks to wake you up to the advantages of insulin? No, I am not talking to those that are managing with diet and exercise, or those that have managed to maintain HbA1c's of 6.5 or less, although they should read this also and learn about insulin. I am directing this to those that consistently have A1c's of 6.6 and greater. These people are in line to develop the complications and probably already have problems with one or more of them.
If you are like me, you may have been diagnosed late, or the doctor has not tried to educate you in managing your diabetes for best management or has discouraged you from testing. These are the people that need to consider insulin for their treatment now.
Read about the myths with facts refuting them here and my blog on insulin myths here. Read what this doctor writes and draw your own conclusions.
The insulin myths are just that – a myths. Why is this used by so many doctors? Is it to get compliance with oral medications? - yes. Do the doctors do anything to remove any of the myths and tell the patient that there is nothing to the myths? - seldom. Is it to get patients to make lifestyle changes? - maybe. Is it to get patients to educate themselves? - no.
An editorial (by David Marrero, PhD – Associate Editor) in the July 2010 issue of Diabetes Forecast, that I have a copy of, was written about a year ago and is still relevant today as it was then. The author is a Type 1 and has an excellent understanding of the problems that people with Type 2 diabetes encounter. The last paragraph in the editorial is the best.
Quote – How should you regard insulin if you have type 2 diabetes? Well, of all the treatment options currently available, insulin is the one with which we have the most experience (over 80 years), the least artificial (the human body naturally makes and needs insulin), and often the most potent. It is one of several medications, not a treatment of last resort. If you have type 2, I suggest that you discuss with your doctor whether insulin is a good choice for you now. Don't wait until you have run out of options. Unquote (emphasis is mine).
What is it going to take folks to wake you up to the advantages of insulin? No, I am not talking to those that are managing with diet and exercise, or those that have managed to maintain HbA1c's of 6.5 or less, although they should read this also and learn about insulin. I am directing this to those that consistently have A1c's of 6.6 and greater. These people are in line to develop the complications and probably already have problems with one or more of them.
If you are like me, you may have been diagnosed late, or the doctor has not tried to educate you in managing your diabetes for best management or has discouraged you from testing. These are the people that need to consider insulin for their treatment now.
Read about the myths with facts refuting them here and my blog on insulin myths here. Read what this doctor writes and draw your own conclusions.
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